Prospective Stratified Randomized Four-Group Study of Cabin Class and Graduated Compression Stockings on Popliteal Vein Dilation After Long-Haul Air Travel After Aesthetic Surgery
2026년 9월 7일 업데이트: Research Inc
This four-group prospective study will enroll travelers who have independently booked economy or premium business/first-class flights to Bogota.
Within each cabin stratum, participants will be randomized to moderate graduated compression stockings or no stockings.
Bilateral popliteal vein ultrasound will be performed before flight, within 2 hours after arrival, and at 24 and 48 hours.
The primary outcome is the interaction between cabin class and compression assignment for change in mean bilateral popliteal vein diameter.
연구 개요
상태
모병
상세 설명
Participants will enter the study according to their prebooked cabin class and then be randomized within that stratum to wear properly fitted knee-high graduated compression stockings or no compression during the flight.
The design creates four groups.
Standardized bilateral ultrasound will quantify venous diameter and cross-sectional area before departure and through 48 hours after arrival, before surgery.
Mixed-effects models will estimate the randomized stocking effect, the adjusted cabin-class association, and their interaction.
The protocol will record seat characteristics, ambulation, hydration, adherence, symptoms, and safety events.
연구 유형
중재적
등록 (추정된)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: hugo Aguilar, MD, Plastic surgeon
- 전화번호: +57 301 6918526
- 이메일: havplasticacademy@gmail.com
연구 장소
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Bogotá, 콜롬비아
- 모병
- Clinica INO
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연락하다:
- hugo Aguilar, MD, Plastic surgeon
- 전화번호: +57 3016918526
- 이메일: havplasticacademy@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age 18 to 65 years.
- Commercial itinerary to Bogota with at least 4 hours of total airborne time.
- Prebooked premium business/first-class or economy-class cabin documented before randomization.
- No medical requirement for or contraindication to graduated compression stockings.
- Ability to complete standardized ultrasound before flight and through 48 hours after arrival before surgery.
- Written informed consent.
Exclusion Criteria:
- Current deep venous thrombosis, therapeutic anticoagulation, or severe peripheral arterial disease.
- Pregnancy.
- Lower-extremity skin, neurologic, or anatomic condition preventing safe stocking use or ultrasound.
- Cabin upgrade or downgrade after randomization that changes the prespecified stratum.
- Surgery or major intravenous fluid therapy before the 48-hour examination.
- Inability to follow the randomized stocking assignment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Economy Cabin Plus Compression
Participants with a prebooked economy itinerary randomized to knee-high moderate graduated compression stockings.
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PROPOSED pressure class: 20-30 mmHg at the ankle, properly fitted and worn from approximately 1 hour before boarding through the arrival ultrasound.
Product and pressure class require confirmation.
Linked arm/group(s): Economy Cabin Plus Compression, Premium Cabin Plus Compression.
Prebooked and completed economy-cabin travel; seat characteristics and behavior are measured but not assigned.
Linked arm/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression.
Triplicate bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours by an assessor masked to stocking allocation.
Linked arm/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression, Premium Cabin Plus Compression, Premium Cabin Without Compression.
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활성 비교기: Economy Cabin Without Compression
Participants with a prebooked economy itinerary randomized to no compression stockings.
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Prebooked and completed economy-cabin travel; seat characteristics and behavior are measured but not assigned.
Linked arm/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression.
Triplicate bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours by an assessor masked to stocking allocation.
Linked arm/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression, Premium Cabin Plus Compression, Premium Cabin Without Compression.
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|
실험적: Premium Cabin Plus Compression
Participants with a prebooked business/first-class itinerary randomized to knee-high moderate graduated compression stockings.
|
PROPOSED pressure class: 20-30 mmHg at the ankle, properly fitted and worn from approximately 1 hour before boarding through the arrival ultrasound.
Product and pressure class require confirmation.
Linked arm/group(s): Economy Cabin Plus Compression, Premium Cabin Plus Compression.
Triplicate bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours by an assessor masked to stocking allocation.
Linked arm/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression, Premium Cabin Plus Compression, Premium Cabin Without Compression.
Prebooked and completed business/first-class travel; seat characteristics and behavior are measured but not assigned.
Linked arm/group(s): Premium Cabin Plus Compression, Premium Cabin Without Compression.
|
|
활성 비교기: Premium Cabin Without Compression
Participants with a prebooked business/first-class itinerary randomized to no compression stockings.
|
Triplicate bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours by an assessor masked to stocking allocation.
Linked arm/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression, Premium Cabin Plus Compression, Premium Cabin Without Compression.
Prebooked and completed business/first-class travel; seat characteristics and behavior are measured but not assigned.
Linked arm/group(s): Premium Cabin Plus Compression, Premium Cabin Without Compression.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cabin-Class-by-Compression Interaction in Change in Popliteal Vein Diameter
기간: Within 24 hours before departure and within 2 hours after arrival at the study site. 3 days
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Interaction term between prebooked cabin stratum and randomized stocking assignment for the change in participant-level mean bilateral popliteal vein diameter from preflight baseline to arrival.
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Within 24 hours before departure and within 2 hours after arrival at the study site. 3 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Randomized Compression Stocking Effect on Arrival-Related Diameter Change
기간: Within 24 hours before departure and within 2 hours after arrival. 3 days
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Adjusted mean difference between stocking and no-stocking assignments overall and separately within each cabin stratum.
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Within 24 hours before departure and within 2 hours after arrival. 3 days
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Adjusted Cabin-Class Association With Arrival-Related Diameter Change
기간: Within 24 hours before departure and within 2 hours after arrival. 3 days
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Adjusted mean difference between premium and economy cabin groups overall and separately by stocking assignment.
This contrast is observational because cabin class is not randomized.
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Within 24 hours before departure and within 2 hours after arrival. 3 days
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Four-Group Popliteal Vein Diameter Trajectory
기간: Within 24 hours before departure; within 2 hours after arrival; 24 +/- 2 hours; and 48 +/- 2 hours after arrival. 3 days
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Estimated mean bilateral diameter and change from baseline in each of the four groups across postarrival time points.
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Within 24 hours before departure; within 2 hours after arrival; 24 +/- 2 hours; and 48 +/- 2 hours after arrival. 3 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Hugo Aguilar
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 1월 12일
기본 완료 (실제)
2026년 9월 1일
연구 완료 (추정된)
2026년 12월 1일
연구 등록 날짜
최초 제출
2026년 9월 2일
QC 기준을 충족하는 최초 제출
2026년 9월 7일
처음 게시됨 (실제)
2026년 9월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 7일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 018
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
not contempled in the patient informed concent
약물 및 장치 정보, 연구 문서
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아니
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